FDA.reportPublic FDA data

DERMAKLEEN

Product NDC
61924-092
Requested package NDC
61924-092-16
11-digit product format
619240092
Labeler code
61924
Product ID
61924-092_d57e4b6c-0b21-7ab2-e053-2995a90a77e4
Type
HUMAN OTC DRUG
Nonproprietary name
ANTIMICROBIAL DRUG PRODUCT
Dosage form
SOAP
Route
TOPICAL
Labeler
Dermarite Industries LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-05-15
Marketing end
0000-00-00
Substance
CHLOROXYLENOL
Active strength
0 g/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61924-092-012024-12-06DRUG LISTING: DERMAKLEEN
61924-092-082024-12-06DRUG LISTING: DERMAKLEEN
61924-092-162024-12-06DRUG LISTING: DERMAKLEEN
61924-092-272024-12-06DRUG LISTING: DERMAKLEEN
61924-092-342024-12-06DRUG LISTING: DERMAKLEEN
61924-092-012024-01-30DRUG LISTING: DERMAKLEEN
61924-092-082024-01-30DRUG LISTING: DERMAKLEEN
61924-092-162024-01-30DRUG LISTING: DERMAKLEEN
61924-092-272024-01-30DRUG LISTING: DERMAKLEEN
61924-092-342024-01-30DRUG LISTING: DERMAKLEEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-092-01DERMAKLEEN3800 mL in 1 JUGSOAP380011
61924-092-08DERMAKLEEN222 mL in 1 BOTTLE, PUMPSOAP22211
61924-092-11DERMAKLEEN1000 mL in 1 BOTTLESOAP100011
61924-092-27DERMAKLEEN800 mL in 1 BAGSOAP80011
61924-092-34DERMAKLEEN1000 mL in 1 BAGSOAP100011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChloroxylenolACTIVE INGREDIENT0F32U78V2QDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
D&C GREEN NO. 6INACTIVE INGREDIENT4QP5U84YF7DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
DMDM HydantoinINACTIVE INGREDIENTBYR0546TOWDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
MethylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
MethylisothiazolinoneINACTIVE INGREDIENT229D0E1QFADERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
Sodium Laureth SulfateINACTIVE INGREDIENTBPV390UAP0DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RDERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-092DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]11Legacy NDC, 5 package rows20241208_ff28985e-d941-4350-971f-fdc2dbbb93bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549613chloroxylenol 0.2 % Medicated Liquid SoapPSNff28985e-d941-4350-971f-fdc2dbbb93bb11
1549618Dermakleen 0.2 % Medicated Liquid SoapPSNff28985e-d941-4350-971f-fdc2dbbb93bb11
1549618chloroxylenol 2 MG/ML Medicated Liquid Soap [Dermakleen]SBDff28985e-d941-4350-971f-fdc2dbbb93bb11
1549613chloroxylenol 2 MG/ML Medicated Liquid SoapSCDff28985e-d941-4350-971f-fdc2dbbb93bb11
1549618Dermakleen 2 MG/ML Medicated Liquid SoapSYff28985e-d941-4350-971f-fdc2dbbb93bb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61924-092-1661924009216473 mL in 1 BOTTLE, PUMP (61924-092-16) 473 ml2020-09-090000-00-00NoNoCurrent